Comparing Astragalus Plus Gemcitabine to Gemcitabine Alone as Neoadjuvant Treatment for Pancreatic Cancer Patients

Pancreatic Cancer Clinical Trial

Official title:

Comparison of Neoadjuvant Treatment for Pancreatic Cancer: Astragalus Combined With Gemcitabine Versus Gemcitabine Alone - A Single-Center, Randomized, Double-Blind Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06234072
• Other study ID #: GEN-SUR-001
• Secondary ID: 82104596
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: February 2024
• Est. completion date: January 2027

Study information

• Verified date: January 2024
• Source: Shenzhen University General Hospital
• Contact: Wei Zhang, PhD
• Phone: +8618616835965
• Email: zhangwei9501[@]szu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study compare the efficacy of Astragalus combined with Gemcitabine to Gemcitabine alone as neoadjuvant treatment for pancreatic cancer.

Description:

Astragalus is a commonly used traditional Chinese medicine in China, which has been widely applied to enhance the immunomodulatory function of the body and suppress the growth of tumors. It was often combined with other herbs to strengthen the body against disease. The effects and mechanisms of Astragalus and Shenqi Fuzheng Injection (the main ingredients are Codonopsis and Astragalus) in the treatment of digestive tract diseases were studied. Investigators found that Astragalus can not only inhibit the growth of pancreatic tumors, but also down regulate the ability of CAFs to secrete βig-h3, thereby inducing CD8+T proliferation and inhibiting the polarization of macrophages into M2 macrophages, thereby enhancing the response of pancreatic tumors to gemcitabine and other treatment options.

Thus, the objective of this study is to compare the impact of combining Astragalus with Gemcitabine versus Gemcitabine alone as neoadjuvant treatment for pancreatic cancer.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: January 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma;

• Is 18 years of age or older;

• ECOG performance status 0 to 2;

Patient organ function tests must meet the following laboratory parameters:

• Transaminases AST (SGOT) and ALT (SGPT) = 2.5 times the upper limit of normal (ULN). If liver function abnormalities are due to underlying liver metastasis, then AST (SGOT) and ALT (SGPT) may be = 5 times ULN.

• Total serum bilirubin = 3.0 times ULN (if due to underlying liver metastasis, then total bilirubin may be = 5 times ULN),

• Neutrophils 1,500/Ul,

• hemoglobin > 8.0 gm/dL,

• Platelet count = 100,000/mm3 (IU: = 100 x 109/L),

• serum creatinine < 2.0 mg/dL,

• Expected postoperative survival = 3 months;

• Ability to comply with the study visit plan and other protocol requirements;

• Voluntary participation and signing of informed consent.

• Is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

• CNS damage or soft meningeal disease;

• Metastasis to distant sites;

• Other serious diseases or conditions, including congestive heart failure (New York Heart Association class III or IV), unstable angina pectoris, infarction in the past 6 months, severe arrhythmia, prolonged QT interval, active HIV infection or HIV disease, mental disorders, and substance abuse;

• Known hypersensitivity to Astragalus or gemcitabine;

• Pregnant or lactating women. Women of childbearing potential who are unwilling or unable to use an acceptable method of contraception throughout the treatment period of this trial and for 12 weeks after the last dose of study drug. Sexually active, fertile men who are not using effective contraception themselves if their partner is a woman of childbearing potential;

• Known neuroendocrine tumor of the pancreas;

• Receiving a concomitant treatment with drugs interacting with gemcitabine;

• Past or concurrent cancers with primary foci or histology completely different from pancreatic cancer, except for cervical cancer in situ, previously treated basal cell carcinoma, and superficial bladder tumors (Ta, Tis & T1). Any cancer cured >5 years prior to enrollment is allowed;

• Inability to swallow herbal medicines or untreated malabsorption syndrome and unwillingness to take herbal medicines.

• Patients with poor compliance

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Astragalus + Gemcitabine
Participants will receive Astragalus combined with Gemcitabine. Astragalus, a traditional Chinese medicine, exhibits promising potential in cancer treatment. Studies suggest its role in regulating immune responses, suppressing tumors, and improving overall treatment outcomes in cancer patients. Astragalus combined with chemotherapeutic drug such as Gemcitabine is a popular complementary and alternative therapy used for cancer patients because it can increase therapeutic effects and decrease side effects. This synergistic approach holds potential for more effective and targeted therapeutic outcomes in pancreatic cancer patients.
• Gemcitabine alone
Gemcitabine is a potent chemotherapy drug widely employed in treating various cancers, including pancreatic cancer. As a nucleoside analog, it disrupts DNA synthesis, impeding cancer cell proliferation. Gemcitabine is administered intravenously and has shown efficacy in alleviating symptoms, improving survival rates, and enhancing the quality of life for patients undergoing cancer treatment.

Locations

Country	Name	City	State
China	Shenzhen University General Hospital	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen University General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR)	Objective response rate (ORR) measures the overall treatment response by assessing the percentage of patients with complete or partial tumor shrinkage after treatment.	From first dose of study medication until approximately 3 years
Secondary	Surgical resection rate	Surgical resection rate refers to the percentage of patients who undergo surgical removal (resection) of a tumor or diseased tissue as part of their medical treatment.	From first dose of study medication until approximately 1 year
Secondary	Percentage of patients with a 50% decrease in CA19-9	Percentage of patients with a 50% decrease in CA19-9 measures the proportion of individuals whose CA19-9 tumor marker levels have reduced by at least 50%, indicating a potential positive response to treatment	From first dose of study medication until approximately 3 years
Secondary	Safety and Tolerance of Chemotherapeutic Drugs (CTCAE)	Safety and Tolerance of Chemotherapeutic Drugs refers to the assessment of adverse events and side effects associated with chemotherapy, using the Common Terminology Criteria for Adverse Events (CTCAE) scale, which evaluates the safety profile and tolerability of chemotherapy in patients.	From first dose of study medication until 30 days after the end of treatment, up to approximately 3 years
Secondary	Progression-free survival(PFS)	From first dose of study medication until disease progression, permanent discontinuation of study treatment, or death due to any cause, up to approximately 3 years.	From first dose of study medication until disease progression, permanent discontinuation of study treatment, or death due to any cause, up to approximately 3 years
Secondary	Overall Survival (OS)	OS will be calculated as date of death minus date of first dose of study medication plus 1. In the absence of death confirmation, OS will be censored at the date of last study follow-up. Analysis will be performed by Kaplan-Meier method.	From first dose of study medication until disease progression, permanent discontinuation of study treatment, or death due to any cause, up to approximately 3 years
Secondary	Proportion of participants with R0 resection	R0 resection rate signifies the percentage of surgical procedures in which the entire tumor is successfully removed with no residual cancerous tissue remaining (complete microscopic tumor removal).	From first dose of study medication until approximately 1 year